6333 - Lead CQV Engineer / Lead Validation Engineer

DescriptionVerista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.Company Culture Guidelines & Values:We empower and support our colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.We constantly acquire new skills and learn from our experiences to enhance our collective expertiseLead Validation Engineer Responsibilities:Lead second shift CQV execution activities across multiple systems and workstreamsCoordinate daily execution priorities to recover schedule slippage and maintain timelinesInterface with QA, Engineering, and Operations to resolve issues in real timeOversee execution of IQ/OQ protocols and operational verification activitiesSupport and review:Drawing walkdownsEquipment and component verificationMaterials of Construction (MOC) and weld verificationProvide oversight for temperature mapping and validation activitiesSupport SIP/CIP and related cycle development activities as neededEnsure all documentation meets GMP/GDP and audit-ready standardsDrive deviation identification, escalation, and resolutionJob Requirements:Bachelor’s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)8+ years of CQV/validation experience in pharma or biotechStrong hands-on execution background with process equipment (bioreactors, filtration, chromatography, UF)Proven experience leading validation teams or shift-based execution effortsStrong GMP/GDP knowledgeExperience with eVal (required), ValGenesis a plusExperience with temperature mapping (Ellab a plus)This role is for 2nd shift. Must be able to work second shift (2-10 PM EST) and weekendsThis role requires the ability to be on-site, full-time in Devens, MA.For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.*Verista is an equal opportunity employer.National (US) Range: $87,780 USD - $140,000 USDBenefitsWhy Choose Verista?High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and BereavementVerista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.For more information about our company, please visit us at Verista.com